Dispensing Evaluation of a Prototype Contact Lens and a Marketed Contact Lens

NCT01094743 | Completed Results FDA Device

• 1 other identifier: CR-1636AZ
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to compare visual acuity and redness of eyes between a prototype contact lens and an already marketed contact lens.

Conditions

Myopia

Outcome Measures

Primary Outcomes (4)

• Visual Acuity Monocular

  Snellen monocular visual acuity measurement

  after 1 week of lens wear

• Visual Acuity Binocular

  Snellen binocular visual acuity measurement

  after 1 week of lens wear

• Subjective Assessment of Lens Comfort

  Contact Lens User Experience (CLUE)TM questionnaire: A validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response.

  after 1 week of lens wear

• Subjective Assessment of Quality of Vision

  Contact Lens User Experience (CLUE)TM questionnaire: A validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response.

  after 1 week of lens wear

Secondary Outcomes (3)

• Limbal Redness

  after 1 week of lens wear

• Bulbar Redness

  after 1 week of lens wear

• Subjective Assessment of Lens Comfort

  10 minutes after lens insertion at time of initial lens fitting

Study Arms (2)

galyfilcon A prototype lens / lotrafilcon B lens

OTHER

The galyfilcon A prototype lenses will be worn during the first period and lotrafilcon B lenses will be worn during the second period. Each period consists of daily lens wear for one week.

Device: galyfilcon A prototype lens; Device: lotrafilcon B lens

lotrafilcon B lens / galyfilcon A prototype lens

OTHER

The lotrafilcon B lenses will be worn during the first period and galyfilcon A prototype lenses will be worn during the second period. Each period consists of daily lens wear for one week.

Device: galyfilcon A prototype lens; Device: lotrafilcon B lens

Interventions

galyfilcon A prototype lens DEVICE

Silicone hydrogel contact lens

galyfilcon A prototype lens / lotrafilcon B lens; lotrafilcon B lens / galyfilcon A prototype lens

lotrafilcon B lens DEVICE

Silicon Hydrogel contact lens

galyfilcon A prototype lens / lotrafilcon B lens; lotrafilcon B lens / galyfilcon A prototype lens

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• The subject must be at least 18 years of age and no more than 39 years of age.
• The subject is a current spherical soft contact lens wearer (defined as a minimum of 6 hours of DW for a minimum of 1 month prior to the study) and willing to wear the study lenses on a daily wear basis (defined as a minimum of 6 hours of wear per day at least five days of the week) for the duration of the study.
• The subject's optimal vertexed spherical equivalent distance correction must be between -1.00 and - 9.00D.
• Any cylinder power must be ≤ -0.75D.
• The subject must have visual acuity best correctable to 20/25+3 or better for each eye.
• The subject must read and sign the Statement of Informed Consent.
• The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.

You may not qualify if:

• Ocular or systemic allergies or disease which might interfere with contact lens wear.
• Systemic disease or use of medication which might interfere with contact lens wear.
• Clinically significant (grade 3 or 4) corneal edema, corneal vascularization, corneal staining, or any other abnormalities of the cornea which would contraindicate contact lens wear.
• Clinically significant (grade 3 or 4) tarsal abnormalities or bulbar injection which might interfere with contact lens wear.
• Any ocular infection.
• Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
• Pregnancy or lactation.
• Diabetes.
• Infectious diseases (e.g. hepatitis, tuberculosis) or an immuno-suppressive disease (e.g. HIV).
• Habitual contact lens type is toric, multifocal, or is worn as extended wear.

Sponsors & Collaborators

• Johnson & Johnson Vision Care, Inc.: lead

Study Sites (2)

Unknown Facility

Jacksonville, Florida, United States

Location

Unknown Facility

Salem, Virginia, United States

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: Huan Sheng, MD, PhD
• Organization: Johnson & Johnson Vision Care

HSheng2@its.jnj.com

1-904-443-3440

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2010
• First Posted: March 29, 2010
• Study Start: February 1, 2010
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: June 19, 2018
• Results First Posted: January 25, 2012

Record last verified: 2017-09

Locations

US (2)